CROS Reverse Osmosis Systems producing Purified Water (PW)
Purified Water (PW) by CROS systems, as defined by USP, Ph Eur, JP, ChP and IP monographs, is classified for pharmaceutical use as an excipient in the production of non-parenteral preparations and for other pharmaceutical applications, such as for CIP cleaning of production equipment and for washing of non-parenteral product-contact components. Feedwater for devoted pretreatments, coupled to CROS systems to produce PW, should be drinkable water with following characteristics:
PARAMETER |
VALUE |
Conductivity |
≤ 600 µS/cm |
Total hardness |
≤ 25°f |
Turbidity |
≤ 1 NTU |
Free Chlorine |
≤ 0.5 ppm Cl2 |
Iron |
≤ 0.1 ppm Fe |
Manganese |
≤ 0.1 ppm Mn |
Silica |
≤ 10 ppm SiO2 |
Temperature |
15 – 20 °C |
Arsenic III |
< 10 µg/l |
Arsenic V |
< 10 µg/l |
TDS |
< 400 |
SDI |
< 3 |
Turbidity |
< 1 |
Faecal Coliform |
Absent |
Faecal Streptococcus |
Absent |
Pseudomonas Aeruginosa (ATCC 9027) |
Absent |
Yeast and Mould |
Absent |
Total microbial count @ 22°C (UNI EN ISO 6222:2001) |
Absent |
Total microbial count @ 37°C (UNI EN ISO 6222:2001) |
Absent |
|
PURIFIED WATER IN BULK* *update Jan 31 2021
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| PHISICAL / CHEMICAL | Ph. Eur. | USP |
| Appearance | Colorless, clear | Not defined |
| Conductivity | ≤ 4.3 μS/cm@20°C | ≤ 1.3 μS/cm@25°C |
| TOC | ≤ 0.5 mg/l | ≤ 0.50 mg/L |
| Nitrates NO₃ | ≤ 0.2 ppm | Not defined |
|
MICROBIOLOGICAL |
Ph. Eur. | USP |
| Bacterial count | ≤ 100 CFU/ml | ≤ 100 CFU/ml |
| Bacterial endotoxins | < 0.25 IU/ml | – |
